CMOCO/CGL Laboratory Compliance and Quality Manager
About The Position
The Colorado Molecular Correlates Laboratory (CMOCO) and Colorado Genetics Laboratory (CGL) are state-of-the-art clinical molecular diagnostic and cytogenetic laboratories within the Department of Pathology at the University of Colorado Anschutz School of Medicine. CMOCO focuses on molecular diagnostic medicine for cancer and constitutional cells, utilizing platforms like next-generation sequencing (NGS) and targeted testing. CGL offers comprehensive cytogenetic testing for constitutional and oncology disorders, including chromosome analysis, FISH, and chromosomal microarray. Both laboratories are CLIA certified, CAP accredited, and operate under validated protocols, including FDA-approved assays and laboratory-developed tests. They are high-complexity, high-volume reference laboratories serving clients across Colorado and the United States. The Laboratory Compliance and Quality Manager is a shared position overseeing all quality aspects for both CMOCO and CGL. This role ensures adherence to CLIA regulations, CAP accreditation standards, and University of Colorado policies. Key responsibilities include developing and maintaining the quality management system, quality assurance, quality control, and quality improvement programs. The manager will also manage document control systems, monitor laboratory metrics, oversee non-conforming event reporting and investigation, and ensure the laboratories are inspection-ready. Proactive workflow evaluation and process improvement initiatives are crucial for enhancing regulatory compliance, operational efficiency, and test quality. This position requires close collaboration with laboratory managers, directors, and technologists to ensure a cohesive quality management system.
Requirements
- A bachelor’s degree from an accredited institution
- 4 years of professional experience in laboratory quality control, quality assurance, and regulatory compliance
- Experience with Next Generation Sequencing (NGS) and/or chromosomal microarray
- Certification by ASCP in cytogenetics (CG) or Molecular (MB) OR certification by quality management professional bodies (e.g. ASQ, RAC, LQMS, etc.) or equivalent
- Applicants must meet minimum qualifications at the time of hire.
- Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.
Nice To Haves
- An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
- Experience in establishing and maintaining clinical laboratory quality management systems, including but not limited to: IQ/OQ, proficiency testing, competency assessment, non-conforming events, document control.
- Experience analyzing laboratory data using qualitative, quantitative and statistical methods including but not limited to: regression analysis, Westgard rules, confidence intervals, Levey-Jennings analysis, root cause analysis, fishbone analysis
- Experience in national regulatory requirements related to molecular diagnostics and cytogenetics, including but not limited to: DexZ/MolDx code submission, laboratory developed tests, inspection from accrediting agencies (CAP, The Joint Commission, etc.)
- Experience working with laboratory information systems or electronic data systems.
- 5 years experience working in a high-complexity clinical laboratory.
- Previous experience in personnel supervision
Responsibilities
- Documenting, maintaining, and updating laboratory quality management systems for CMOCO and CGL, including assay quality control and assurance, proficiency testing, instrument performance monitoring, and personnel compliance records such as education, certification, and competency assessment
- Overseeing document control to support the quality management systems for CMOCO and CGL
- Serving as a subject matter expert and leader in regulatory compliance and quality assurance including, monitoring relevant regulatory changes, coordinating CAP inspections, and communicating regulatory requirements and changes to the laboratory
- Participating in data management, analysis, and statistical reporting of quality metrics, including identifying trends and opportunities for improvement
- Participating in and leading workflow evaluation and process improvement initiatives to enhance laboratory efficiency, quality, and compliance
- Leading the reporting, investigation, and resolution of non-conforming events, including root cause analysis and implementation of corrective and preventive actions to facilitate continuous quality improvement in both laboratories
- Performing additional quality and compliance related activities as required to support laboratory operations
Benefits
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 10/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
